UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041257 |
|---|---|
| Receipt number | R000047102 |
| Scientific Title | The Relation of Breast-feeding and Eating Behavior from 9-month-olds to 47-month-olds children. |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2021/08/10 16:53:41 |
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Basic information
Public title
The Relation of Breast-feeding and Eating Behavior from 9-month-olds to 47-month-olds children.
Acronym
The Relation of Breast-feeding and Eating Behavior in toddlers and young children.
Scientific Title
The Relation of Breast-feeding and Eating Behavior from 9-month-olds to 47-month-olds children.
Scientific Title:Acronym
The Relation of Breast-feeding and Eating Behavior in toddlers and young children.
Region
| Japan |
Condition
Condition
None (Healthy children)
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To Clarify the percentage of a breast-feeding and eating behavior in children who are weaning or already had weaned.
2. To find some factors that a breast-feeding style is affected eating behavior.
Basic objectives2
Others
Basic objectives -Others
To consider the suitable usage of a bottle and nipple in infants and toddlers, and the transition from breast-feeding to weaning.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will conduct the online survey that hear from mothers about their children's feeding condition and style, eating condition or something.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 9 | months-old | <= |
Age-upper limit
| 47 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Children who are breast-feeding, bottle-feeding, mixed, or already weaning.
2. Children who eat solid food including baby food from their mouth.
3. Mothers who agree to join our online survey.
Key exclusion criteria
1. Children who are delay to motor development.
2. Children who are only breast-milk or artificial milk.(ever have not eaten baby food or solid food)
3. Children who are tube feeding.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Sumiko |
| Middle name | |
| Last name | Kuroishi |
Organization
Pigeon Corporation
Division name
Research and Development DIV. Breast-feeding Lab.
Zip code
300-2495
Address
6-20-4, Kinunodai, Tsukubamirai-shi, Ibaraki 300-2495, Japan
TEL
0297-52-6532
sumiko.kuroishi@pigeon.com
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Osugi |
Organization
Pigeon Corporation
Division name
Research and Development DIV. Breast-feeding Lab.
Zip code
300-2495
Address
6-20-4, Kinunodai, Tsukubamirai-shi, Ibaraki 300-2495, Japan
TEL
0297-52-6532
Homepage URL
yoshimi.oosugi@pigeon.com
Sponsor or person
Institute
Pigeon Corporation, and Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Pigeon Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Macromill, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
03-6240-1162
jimukyoku@tes-h.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社マクロミル（東京都）／ Macromill, Inc. (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
-
Publication of results
Published
Result
URL related to results and publications
https://www.jschild.med-all.net/Contents/private/cx3child/2021/0080s1/219/0196-0196.pdf
Number of participants that the trial has enrolled
764
Results
The continuation of breastfeeding or bottle-feeding should affect on the amount of eating, how to eat, and the usage of tableware compared to children who already finished breastfeeding. For example, breast-feeding and bottle-fed children tended to have an unbalanced diet, small meals, and a low proportion of eating by themselves with their hands or spoon.
Results date posted
| 2021 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Number of valid answers; n=512
Some answers were deleted as below reasons; inadequate answers, children who were delayed in motor development, or children who have eaten baby food in first stage only or have never eaten baby food.
Participant flow
The cross tabulation analysis were conducted by the situation of feeding based on the age.
Adverse events
None
Outcome measures
If the cell were under 30 numbers, these data were analyzed as reference information.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 07 | Month | 30 | Day |
Last modified on
| 2021 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047102
